PROJECT SUMMARY Rapid oral test for Influenza A+B diagnostics The goal of this project is to develop rapid oral test for diagnostics of influenza A+B. Influenza is a highly contagious viral infection of the respiratory tract that causes disease in millions of people globally. Influenza outbreaks occur each year and the associated costs in the US exceed $10 billion annually. Recently, effective antiviral therapy for influenza became available. The therapy needs to be initiated within 2 days of symptom onset to be effective, which raised the importance of influenza testing in Point-of-care (POC). The gold standard for objective diagnostics of influenza infection is a laboratory RT-PCR assay. Rapid Influenza Diagnostic Tests (RIDT) provide solution for POC diagnostics. RIDTs are disposable immunoassays that detect Influenza A and B antigens in <30 min. RIDT have major weaknesses limiting their clinical utility: (i) The nasopharyngeal swab (NPS) specimen is invasive to obtain. (ii) The sensitivity is low (11-91%). There is unmet need for a noninvasive RIDT with high sensitivity. The ultimate goal of this project is to develop oral RIDT that will use whole saliva specimen. Key advantages of oral RIDT compared to NPS RIDT: 1/ Noninvasive sample. Saliva can be collected easily, safely and noninvasively. This is a major advantage over NPS, in particular for children and seniors. 2/ High sensitivity. Oral RIDT has potential for a higher sensitivity than the NPS RIDT because the concentration of detectable influenza antigen in saliva can be increased by lysing saliva epithelial cells to release cell-associated viral proteins. The proposed Phase I study will provide a proof of concept for influenza A immunoassay in saliva sample. SA1 will show analytical feasibility of measuring major influenza A antigens: NP, HA and NA, in whole saliva. SA2 will leverage existing saliva samples from patients diagnosed with influenza A to show feasibility of detecting influenza A antigens in clinical saliva. Expected Outcomes: The proposed Phase I SBIR research will demonstrate the feasibility of oral test for influenza diagnostics. The scientific premise is strong based on recent discovery of high influenza viral load in in patient saliva and buccal cells. Demonstration of technical feasibility in SA2 will provide GO criteria for development of a commercial oral RIDT for Influenza A+B in Phase II. If successful, the project has potential for high impact by providing noninvasive, highly sensitive oral test for influenza diagnostics that will enable immediate, effective treatment decisions in POC. The proposed oral influenza test has a strong commercial potential based on no competition and existing team of proven industry partners.